Problems in antiemetic trial design and interpretation.

Research in the control of chemotherapy-induced nausea and vomiting is a relatively new endeavor. Accurate assessment of clinical trial results assumes a sound study design, control for known variables, clear definitions, and reproducible assessment criteria. In most of these areas, antiemetic trials still lag behind cancer treatment trials. This paper reviews 44 antiemetic trials and discusses the state of the art in antiemetic research methodology, examining how a representative sample of investigators have addressed patient selection criteria, study design, and assessment parameters. Comparisons with the chemotherapy literature suggest approaches to improve the antiemetic literature and optimize our use of the data derived from it.